(28 days)
The Wholey Guide Wire System is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guide wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
The Wholey™ Guide Wire System is a 0.035" guide wire available in lengths of 145, 175, 260 and 300cm. The distal tip flex configurations are Standard, Floppy, and Intermediate. Tip shape is Straight or Modified J. The guidewire is composed of a stainless steel core, green PTFE (polytetrafluoroethylene) coated coil, white PTFE sleeve, platinum-tungsten marker coil, and optional extension system connector. The proximal end of the core is covered by a white PTFE sleeve that terminates at 100cm from the distal tip. The distal 100cm of the guidewire is covered with a green PTFE pre-coated coil. The PTFE coated coil and platinum-tungsten coil are welded to the core on the very distal tip. The distal tip is shapeable and radiopaque.
A torque device is packaged with the guide wire as an accessory. The polycarbonate/brass torque device is designed to be secured to the proximal portion of a guide wire with a diameter, from 0.020" - 0.040" (0.50mm to 1.01mm) to facilitate steering of the guide wire within the vascular anatomy.
A Wholey Extension Wire is an available accessory consisting of a PTFE coated stainless steel guide wire attachment which is 0.035" (0.900 mm) in diameter and 155 cm in length. It is exclusively compatible with 0.035" (0.900 mm) Wholey guide wires which have been modified for the attachment of the Wholey Guide Wire Extension to facilitate device exchange. Refer to the Wholey Guide Wire Extension instructions for use.
This document describes the performance data for the Wholey™ Guide Wire System. However, it does not present acceptance criteria in a structured table or specifically detail a study proving the device meets those criteria in a quantitative sense as might be done for an AI/CADe device. Instead, it outlines a series of tests performed to establish substantial equivalence to a predicate device.
Here's an attempt to structure the information based on the provided text, while acknowledging the limitations of the original document in providing explicit acceptance criteria and a "study that proves" this in a clear, quantifiable manner typical of AI device evaluations:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests performed to demonstrate equivalence. While explicit numerical acceptance criteria are not provided for each test, the general statement is that "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
| Acceptance Criteria Category (Implied) | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Equivalence | Distal Pull Strength | Met requirements / Demonstrated equivalence |
| Combined Load Torque Response | Met requirements / Demonstrated equivalence | |
| Tip Flexibility | Met requirements / Demonstrated equivalence | |
| Coating Durability | Met requirements / Demonstrated equivalence | |
| Lubricity and Catheter Compatibility | Met requirements / Demonstrated equivalence | |
| Linear Stiffness | Met requirements / Demonstrated equivalence | |
| Dimensional | Met requirements / Demonstrated equivalence | |
| Fracture - ISO Flex - ISO | Met requirements / Demonstrated equivalence | |
| Corrosion | Met requirements / Demonstrated equivalence | |
| Strength of Union – Distal Tip | Met requirements / Demonstrated equivalence | |
| Shape Retention | Met requirements / Demonstrated equivalence | |
| Tip Load | Met requirements / Demonstrated equivalence | |
| Hypotube Flex | Met requirements / Demonstrated equivalence | |
| Jacket Adhesion | Met requirements / Demonstrated equivalence | |
| Body Stiffness (3-Point Bend) | Met requirements / Demonstrated equivalence | |
| Particulate | Met requirements / Demonstrated equivalence | |
| Radiopacity | Met requirements / Demonstrated equivalence | |
| Lateral Stiffness | Met requirements / Demonstrated equivalence | |
| Biocompatibility | Cytotoxicity (per ISO 10993 series) | Test results met the specified acceptance criteria. |
| Thrombogenicity (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Kligman Maximization Test (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Systemic Toxicity (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Rabbit Pyrogen (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Hemolysis (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Complement Activation Assay (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Lee and White Coagulation (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Unactivated Thromboplastin Time Assay (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| USP Physicochemical Test (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Inhibition and Enhancement (per ISO 10993 series) | Test results met the specified acceptance criteria. | |
| Packaging | Pouch Peel | Met requirements / Demonstrated equivalence |
| Dye Penetration | Met requirements / Demonstrated equivalence | |
| Packaging Distribution | Met requirements / Demonstrated equivalence | |
| Thermal Conditioning | Met requirements / Demonstrated equivalence | |
| In Vivo Performance | GLP animal study | Showed the Wholey Guide Wire System is substantially equivalent to the currently marketed predicate device for safety and performance. |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for each bench test. For the GLP animal study, the sample size is not specified but it is referred to as "a GLP animal study."
- Data Provenance: The document refers to "bench testing" and "a GLP animal study." The location or specific country of origin for this testing is not specified, but it was conducted by Covidien LLC, an American company. The studies were likely prospective in nature for their specific evaluation goals.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this submission. The "ground truth" for non-clinical device testing, especially for mechanical and biocompatibility evaluations, is typically defined by standardized test methods (e.g., ISO standards, FDA guidance) and measured physical properties, rather than expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on direct measurements from bench tests and animal study observations, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This submission is for a medical device (guide wire system), not an AI/CADe system. Therefore, MRMC studies involving human readers or AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This submission is for a medical device (guide wire system), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation derived from:
- Physical Measurements and Standards: For bench tests, adherence to specified physical properties (e.g., pull strength, flexibility, dimensions) as defined by established engineering and material science standards, and guided by FDA and ISO guidance (e.g., ISO 11070:1998 for guidewires).
- Biocompatibility Testing Standards: Adherence to biological safety criteria as defined by ISO 10993 series for cytotoxicity, thrombogenicity, etc.
- In Vivo Observations: The GLP (Good Laboratory Practice) animal study provided observational data on safety and performance in a biological system, compared against the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so no "training set" in that context was used. The device design and testing were informed by existing knowledge, engineering principles, and regulatory guidance, not an iterative training process using a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI/ML device.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.